Regulatory Affairs
1 week ago
Details of the requirement are given below for your reference:
1) Client Company : Pharmaceuticals Industry
2) Position : Regulatory Affairs
3) Experience Required : 3+ years
4) Salary Negotiable : Rs PM to 50000 PM
5) Job Location : Ahmedabad
6) Job Description :
A) To review dossier prepared by executives and trainees and submit to client along with artworks for countries like ASIA, LATAM & ROW Market.
B) To work on Renewals of Registration Certificate for countries.
C) Ensure that a companys products comply as per current ICH and Country Guidelines. D) Courier of Legalized Documents such as COPP, FSC, POA, Manufacturing
Agreement, Declaration letters for updation of artworks, GMP certificate to respective clients and countries.
E) Courier of Samples for New registration and Renewal Purpose as per client requirements for reanalysis and first commercial batch analysis purpose.
F) Arrangement of Sample and Legals required as per new registration and Renewal purpose from Legal team, Production department and FRD.
G) Follow up with FRD and Microbiology department for test requirements by client on batch FPCOA.
H) Arrangement and courier of Working Standards from QC department to Client or country as required for testing purpose.
I) Resolving queries from client regarding new registration and renewals as per country requirements.
J) Updation and maintenance of Country Specific Global Status sheets for New registration, Renewals and Query Status.
K) Follow up for Review and corrections of Artworks required for New registration and Renewals with Artwork department as per client and company requirements.
L) Follow up and arrangements of Documents required for Dossier Preparation with QA, QC, ARD and Micro Department as per country guidelines.
Interested candidates can apply immediately.
With Regards,
Gopi (HR)
Job Type: Permanent
Pay: ₹20, ₹50,000.00 per month
Work Location: In person
-
Regulatory Affairs
1 week ago
Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 2,50,000 - ₹ 7,50,000 per year**Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...
-
regulatory affairs
6 days ago
Ahmedabad, Gujarat, India Sunrise Remedies Full time ₹ 15,00,000 - ₹ 28,00,000 per yearSunrise Remedies Job Opening for Regulatory Affairs (RA) officer.Experience: 1 YearIndustries: Pharmaceutical CompanyEducation: B.Sc. | M.Sc | B.Pharm | M.PharmJob Location: Santej Ahmedabad.Facilities Provided:– Transportation Facility Available (As Per Circumference Of Sunrise Remedies)*– Mediclaim and Food Facility provide By Company.*Key...
-
Regulatory Affairs Executive
1 week ago
Ahmedabad, Gujarat, India Vital Group Full time ₹ 12,000 - ₹ 14,90,645 per yearJob Opening: Regulatory Affairs Executive | Vital GroupLocation: SG Highway, AhmedabadExperience: 1–3 years (Pharma Industry)Key Responsibilities:Preparation and submission of dossiers, CTD/ACTD, and regulatory documents.Handling regulatory queries and compliance requirements.Coordination with internal teams to ensure timely submissions.Support in product...
-
Regulatory Affairs Executive
3 days ago
Ahmedabad, Gujarat, India Uniza Group Full time ₹ 6,00,000 - ₹ 12,00,000 per yearCompany DescriptionUniza is part of the $150 M+ Pashupati group of companies, specializing in India Business, International Business, and the manufacturing of tablets, capsules, creams, and ointments. With a strong distribution network across 28 states in India, Uniza has established a significant presence in Dermatology, Cardio-Diabetic, Gynecology, and...
-
Regulatory Affairs Executive
6 days ago
Ahmedabad, Gujarat, India Prompt Career Consultants Full time ₹ 15,00,000 - ₹ 28,00,000 per yearPrepare, submit regulatory dossiers for new product registrationsCoordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profileM. Pharm (Female Candidate Preferred)1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired.Excellent...
-
Manager- Drug Regulatory Affairs
2 weeks ago
Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per yearCompany DescriptionLezivia Lifesciences is a reputed company known for its quality pharmaceutical products. Most of our products are manufactured at WHO-approved facilities, ensuring the highest quality standards for patient care. We are dedicated to delivering the best products to improve patient outcomes and well-being.Role DescriptionThis is a full-time,...
-
Regulatory Affairs Associate
5 days ago
Ahmedabad, Gujarat, India Smart Lion Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRegulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profileBSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Ahmedabad, Gujarat, India Jain Soap & Jain Lifecare Pvt Ltd Full time ₹ 32,00,000 - ₹ 48,00,000 per yearJob Title:Sr. Regulatory ExecutiveLocation:Vadsar, GandhinagarCTC:₹4.0 LPA – ₹6 LPAExperience Required:2–4 years in Regulatory Affairs (Pharma or Cosmetics)Educational Qualification:B.Pharm / M.Pharm – Drug Regulatory Affairs, Quality Assurance, Pharmacology, or Pharmaceutical AnalysisRoles & Responsibilities:Prepare and review dossiers in...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...
-
Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full time ₹ 15,00,000 - ₹ 25,00,000 per yearJob Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended forRest of the World (RoW) markets, ensuring compliance with country-specific...